Thomas 2011.
| Study characteristics | ||
| Methods | Quasi‐RCT | |
| Participants | Infants aged 5 to 15 weeks and receiving their 1st, 2nd, or 3rd doses of DPT immunisation | |
| Interventions | Intervention: Breastfeeding 2 minutes before and during injection Control: No intervention. Position of infant not specified |
|
| Outcomes | Modified NIPS at 1 and 5 minutes following injection. No description given of modifications made to the NIPS. | |
| Notes | Power calculation: No | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Authors did not specify how infants were allocated to each group. They stated "... 20 were assigned to the experimental group and 20 to the control group" (p. 184). They also stated: "Non‐probability purposive sampling technique was found more appropriate to make the study more feasible". It is unclear what this means. |
| Allocation concealment (selection bias) | Unclear risk | The following statement by the authors provided insufficient information to assess this category: "... Who possess their immunisation card were selected, out of which 20 were assigned to the experimental group and 20 to the control group" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of breastfeeding not possible |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessment done at the time of vaccine, therefore blinding of breastfeeding not possible. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 40 infants were included, and data were reported for 40 infants. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
DPT: diphtheria‐pertussis‐tetanus IQR: interquartile range MBPS: Modified Behavioral Pain Scale MFCS: Modified Facial Coding System MMR: measles, mumps, rubella NFCS: Neonatal Facial Coding System NIPS: Neonatal Infant Pain Scale RCT: randomised controlled trial wDPT: whole cell diphtheria‐pertussis‐tetanus